Home Neuromodulation for Neurogenic Bladder Management in Spinal Cord Injury

Home Neuromodulation for Neurogenic Bladder Management in Spinal Cord Injury: A Hybrid Implementation-Efficacy Trial

The purpose of this study is to determine the safety and efficacy of Injectrode Tibial Nerve Stimulation for bladder function in people with spinal cord injury.

Inclusion Criteria:

• Non-progressive chronic (>1 year) SCI
• Neurologic level of injury T9 and above
• Stable over active bladder (OAB) medications (≥3 months)
• No contraindication to MRI (per MRI Safety Questionnaire)
• English or Spanish speaking
• Tolerate and be able to evoke toe flexion bilaterally with transcutaneous tibial nerve stimulation (tTNS) (self or assisted)
• Pass the tTNS competency checklist to perform or direct performance of tTNS.

Exclusion Criteria:

• Ongoing/active genitourinary oncologic diagnoses
• History of other central nervous system disorder (CNS) disorders and/or peripheral neuropathy
• Pregnancy or planning to become pregnant.
• Lower Motor Neuron bladder
• Restorative bladder surgery such as augmentation cystoplasty
• Botulinum toxin-A injections in the bladder within 6 months of trial enrolment (injection in other sites is allowed)
• Anticoagulation treatment or prophylaxis
• Advanced peripheral vascular disease (gangrene, amputation, etc.)
• History of intolerance to electrical stimulation, particularly of the leg